omega study: a study of the safety and feasibility of up-titration with int301 in adults with sensitivity to peanut

Conditions: Peanut Allergy

Summary: this is a phase 1, multi-center, randomized, double-blind, placebo-controlled study in adult participants with peanut allergy. participants will be randomized in a 3:1 ratio to receive either an escalating dose of int301 or placebo. the treatment group will be blinded to the investigator, participants, and the intrommune study team.


Eligibility criteria:
inclusion criteria: participant must be 18-55 years of age inclusive, at the time of signing the informed consent. female participants of childbearing potential or male participants with female partners of child-bearing potential must utilize highly effective birth control method(s) throughout the study and for 30 days after the final dose of study drug. acceptable methods of contraception include: complete abstinence, male or female condoms with spermicide, oral or implanted contraceptives, or vasectomy. for female participants of child-bearing potential: negative serum beta human chorionic gonadotrophin (hcg) pregnancy test at screening. capable of giving signed informed consent as described in appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (icf) and in this protocol. meets at least one of the following conditions * positive skin prick test (spt) (wheal at least 3 mm greater than control) and/or peanut specific ige \>0.35 ku/l * convincing clinical history of allergic reaction to peanut within 1 hour of ingestion for at least 3 months prior to screening. * failed an oral food challenge (ofc) of \< 100mg of peanut protein at screening. * participant willing and able to undergo the procedures required by the protocol, including, assessment completion, protocol compliance, and participation in the placebo dosing period(s). exclusion criteria: * history of severe anaphylaxis to peanut, defined as hypoxia, hypotension, or neurologic compromise (cyanosis or oxygen saturations \< 92% at any stage, hypotension, confusion, collapse, loss of consciousness, or incontinence) * significant medical condition (e.g., liver, kidney, gastrointestinal, cardiovascular, hematologic, or pulmonary disease) which would make the subject unsuitable for induction of food reactions * eosinophilic or other inflammatory (e.g. celiac) gastrointestinal disease * psychiatric disorders that the investigator believes will interfere with study assessments * uncontrolled asthma, defined by at least one of the following conditions: * - fev1 \<80% of predicted, or ratio of fev1 to forced vital capacity (fev1/fvc) \<75% of predicted, with or without controller medications. * - inhaled corticosteroids (ics) dosing of \>500mcg daily fluticasone (or equivalent ics based on nhlbi dosing chart. * - one hospitalization in the past year for asthma * - an er visit for asthma within six months prior to screening * planned dental surgery during from screening until study exit * moderate or advanced periodontal disease. * current pregnancy or lactating

Keywords: peanut allergy food allergy desensitization allergy immunotherapy omit oit epit slit oral mucosal immunotherapy